BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PROMAX SURGICAL DRAPES AND COVERS

    K Number: K980183 · Decision Feb 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    23
    Review Days
    37

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    Basic Information

    Device Name
    PROMAX SURGICAL DRAPES AND COVERS
    K Number
    K980183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Textile Co., Inc.
    Date Received
    January 20, 1998
    Decision Date
    February 26, 1998
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Standard Textile Co., Inc.

    K Number Device Name
    K241214 ProPel SG3™ Surgical Gown
    K172207 Standard Supreme Sterilization Wrapper
    K162162 Barrier Supreme Sterilization Wrapper
    K060181 COMPE1 1 -PLY SURGICAL GOWNS
    K041653 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
    K041540 COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
    K041539 COMPEL SURGICAL GOWNS
    K041541 COMPEL MLR SURGICAL GOWNS
    K012268 TRIMAX
    K012807 MODIFICATION TO: COMPEL SURGICAL DRAPES
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